malignant tumor
Conditions
Interventions
metoclopramide group:metoclopramide
olanzapine combine with metoclopramide group:olanzapine combine with metoclopramide
Sponsors
Hunan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18~65 years; 2. patients who plan to accept chemotherapy including Cisplatin; 3. Blood routine: white blood cell count (WBC)=4.0×10^9/L; Neutrophil count=2×109/L;platelet count=100×10^9/L; 4. Blood biochemistry: total bilirubin=25 umol/L; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)=100 u/L; Serum creatinine=132 umol/L; Creatinine clearance=60 mL/min; 5. No serious cognitive impairment; 6. No known history of central nervous system disease (for example, uncontrolled brain metastases, epilepsy, convulsions); 7. No history of psychosis (such as schizophrenia, bipolar affective disorder, and dementia); 8. No simultaneous intraperitoneal radiotherapy; 9. Anaphylaxis to olanzapine; 10. There is no uncontrolled history of diabetes; 11. Patients with no nausea and vomiting within 24 hours before the start of the trial; 12. No other antipsychotic drugs were used during the first 30 days of the trial or during the trial (for example, Ketone, quetiapine, clozapine, phenothiazine and butylbenzene); 13. No simultaneous use of quinolone antibiotics; 14. No chronic alcoholism; 15. The patient and / or family members know and agree to participate in this test and sign the informed consent; 16. Women of childbearing age must undergo a pregnancy test negative 7 days before the entry of the group. During the observation period and at the last stage, 8 weeks after olanzapine or metoclopramide, the appropriate method of contraception should be adopted. For men, surgical sterilization should be done, or the appropriate method of contraception should be applied in the observation period and within 8 weeks after the last time given olanzapine or metoclopramide.
Exclusion criteria
Exclusion criteria: 1. A severe and non controlled infection; 2. Women in pregnancy or lactation; 3. There are uncontrolled serious heart problems in the last 6 months, such as arrhythmia, heart failure, and acute myocardial infarction; 4. A persistent or uncontrollable systemic disease (such as an unstable or decompensated heart, liver, or kidney disease); 5. Untreated unstable brain or meningeal metastasis; 6. A known history of central nervous system disease (for example, uncontrolled brain metastases, epilepsy, convulsions); 7. History of narrow angle glaucoma; 8. Gastrointestinal bleeding, mechanical obstruction, or perforation; 9. Patients received aprepitant as part of its preventive antiemetic scheme; 10. Patients who have received cytotoxic chemotherapy in the last 5 years; 11. The QT interval of electrocardiogram is more than 480ms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the remission rate of nausea and vomiting in acute stage;the remission rate of nausea and vomiting in delayed period;Total remission rate of nausea and vomiting; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of explosive vomiting; | — |
Countries
China
Contacts
Public ContactHuaxin Duan
Hu'nan Provincial People's Hospital
Outcome results
None listed